ClinicalTrials.gg
RecruitingNCT06619041Updated Sep 1, 2026

HealthyTogether: RCT of a Dyadic Weight Management Intervention

An interventional study of HealthyTogether in Obesity and Overweight, sponsored by VA Office of Research and Development. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-01.

Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Started Jul 2025; still recruiting 1 year 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
320
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 54 studies in Obesity by VA Office of Research and Development — 9 open to participants now, 13 under way, none of them phase 3. Obesity · VA Office of Research and Development.

Planned enrollment
10th of 52
320 · median 122
Started
2025
with 2 others
No phase
47 of 54
8 open now
Primary completion
2027-09
later than 4 of 12 live
Registered
48th of 54
by date

Among the 54 studies in Obesity by VA Office of Research and Development, this one is the 10th largest by planned enrollment of the 52 interventional ones, is one of 3 that started in 2025, is one of 47 with no phase, reaches primary completion later than 4 of the 12 other live ones, and was the 48th registered.

By phase

54 studies; the count open now beside each. This study's row is marked.

No phasethis study47 · 8 open
Observational2 · 0 open
Phase 22 · 1 open
Phase 11 · 0 open
Phase 31 · 0 open
Phase 41 · 0 open

By the year they started

First in 2005; this study’s year is marked. 3 started in 2025.

Size and results

Median enrollment 122 across the 52 interventional studies, 69 across the 2 observational. Of the 39 that completed or were terminated, 34 (87%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 54 studies in Obesity by VA Office of Research and Development, or all of them as a file.
02

Study summary

Four in five Veterans have overweight or obesity. However, few eligible Veterans achieve meaningful weight loss in VA's national MOVE! Weight Management Program. Family and friends strongly influence a person's health behaviors and weight. Including a close family member or friend in weight management may improve weight management outcomes. This study will test whether an 14-week, 8-session virtual weight management program that includes Veterans and a support person (e.g., family member or friend) leads to weight loss. The investigators will also test whether the program leads to improvements in weight-related health behaviors, including physical activity and diet, and relationship quality.

Read the detailed description

The prevalence of overweight and obesity is more than 80% among VA users, increasing risk of morbidity and mortality. In 2006, VA nationally implemented the MOVE! Weight Management Program, an evidence-based behavioral weight management program. Effectiveness of MOVE! is suboptimal: \<20% of all participants and only 30% of those with intense and sustained participation achieve clinically meaningful weight loss. Furthermore, only 8-9% of eligible Veterans attend any MOVE! sessions and, among those who do, half attend only a single session. Taken together, \<2% of the 3.2 million eligible Veterans lose clinically meaningful weight in MOVE!. Therefore, additional weight management approaches are needed to address obesity at the VA population-level.

One strategy to improve behavioral weight management effectiveness is by leveraging social relationships. Social support improves weight management program initiation, retention, and short and long-term weight loss and is also a major driver of weight-related behaviors, such as physical activity and diet quality. However, social relationships can also impede weight management, for example, when close others (e.g., family and friends) undermine or do not support behavior change. The key to addressing this double-edged sword of social relationships may be through dyadic approaches that include close others in behavioral weight management with a focus on improving communication and relationship quality.

HealthyTogether is a brief, virtual weight management program for Veterans and a close other ("partner"). Over 14 weeks, individual dyads receive 8 hour-long video sessions with a clinician. Session content includes physical activity, diet, and weight management medication education; goal setting; and relationship and communication skills training and practice, informed by evidence-based dyadic treatments. This study is a two-site hybrid type I effectiveness-implementation randomized controlled trial with a primary focus on evaluating effectiveness of HealthyTogether and a secondary focus on understanding determinants of implementation. The aims of the trial are:

  1. Test whether HealthyTogether results in greater weight loss than usual care at 6 months among Veterans (primary).
  2. Examine differences between HealthyTogether and usual care groups in secondary Veteran and partner outcomes, including health behaviors (i.e., diet, physical activity) and relationship quality.
  3. Examine Veteran and partner contributions to changes in their own and each other's outcomes using dyadic analyses, informing potential future intervention targets.
  4. Assess determinants of implementation, including cost, feasibility, acceptability, and appropriateness, guided by the Consolidated Framework for Implementation Research, to inform future implementation.

Considering the burden of overweight and obesity in VA and the limited reach and effectiveness of MOVE!, HealthyTogether has the potential to address multiple VA priorities: mitigate obesity-related chronic disease and involve family in Veterans' care. Study findings will inform VA National Center Health for Health Promotion and Disease Prevention efforts to expand effective, evidence-based weight management services for Veterans.

03

Conditions studied

  • Obesity
  • Overweight

Keywords

  • Weight Loss
  • Weight Loss Programs
  • Social Support
  • Diet
  • Physical Activity
  • Virtual Medicine
  • Family
  • Dyadic
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Veteran participants:

  • Assigned to a VA primary care provider
  • Have a weight measurement (>=30) recorded in the VA medical record within 16 weeks prior to enrollment
  • Have a second, valid weight measurement recorded in the VA medical record within the prior year
  • Have a BMI>=30 at enrollment
  • Able to participate in virtual intervention sessions during regular business hours

Partner participants:

  • Able to participate in virtual intervention sessions during regular business hours
  • Speak with Veteran at last weekly
  • Live in the same state where Veteran receives VA care

Exclusion criteria

Exclusion Criteria:

Veterans are excluded if:

  • not fluent in English
  • have severe hearing loss prohibiting participation
  • have a dementia diagnosis
  • have recently (within the past 3 months) participated in a clinical or research behavioral weight management program
  • have a history of (within past 2 years) or plans to (within next 6 months) have bariatric surgery
  • are pregnant, postpartum, nursing, or planning to become pregnant within 6 months
  • are receiving cancer (non-skin) treatment
  • have drug or alcohol dependence not in remission, a recent suicide attempt, active psychosis, or an active behavior flag in the medical record
  • report high-levels of alcohol use (AUDIT-C score >=8)
  • are receiving hospice or palliative care
  • are living in a nursing home or assisted living facility
  • are enrolled in VA home-based primary care
  • have end stage renal disease
  • have a current or past diagnosis of anorexia or bulimia
  • have had an inpatient hospitalization in the past 3 months
  • weigh more than 440 pounds (this is the upper limit of the study's scales)

Partners are excluded if:

  • not fluent in English
  • have severe hearing loss prohibiting participation
  • endorse having a health condition that may limit their ability to participate in the intervention
  • report high-levels of current alcohol use (AUDIT-C score >=8)
  • are receiving hospice or palliative care
  • are living in a nursing home or assisted living facility
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
320 participants (estimated)

Study arms

  • Experimental
    Treatment Arm

    Receives the brief, virtual, dyadic HealthyTogether weight management intervention in addition to usual care.

    Behavioral: HealthyTogether

  • No intervention
    Usual Care Arm

    Receives a brief letter with information about weight management and couples/family resources in addition to usual care.

Interventions

  • BehavioralHealthyTogether

    HealthyTogether is a brief (8-session), virtual, dyadic weight management intervention.

06

What researchers measure

Primary outcomes

  1. Change in weight from Baseline to 6-months among Veterans

    Weight is measured using a study-provided scale during a scheduled virtual study visit. Veterans will either (1) display the weight on the scale to study staff or (2) take a picture of the weight on the scale with a digital device and show the weight to study staff. For weight measurements at both timepoints, we will instruct participants to weigh themselves in light clothing and no shoes, with the scale on a hard, flat surface. We will record date and time of weight assessments and will make every attempt to collect follow-up weights at a similar time of day as baseline.

    Time frame: 6-months

Secondary outcomes

  1. Change in weight from Baseline to 6-months among Veterans (using EHR-data)

    We will collect supplementary EHR-based weights from for all Veteran participants. We will use the EHR weight closest to 182 days +/- 60 days post-baseline. While the primary outcome is limited to Veterans with study team measured weight, secondary analyses will be conducted among all participants with available weight outcomes (staff verified and/or EHR-based).

    Time frame: 6-months

  2. Change in weight from Baseline to 6-months among partners

    Weight is measured using a study-provided scale during a scheduled virtual study visit. Partners will either (1) display the weight on the scale to study staff or (2) take a picture of the weight on the scale with a digital device and show the weight to study staff. We will record date and time of weight assessments and will make every attempt to collect follow-up weights at a similar time of day as baseline.

    Time frame: 6-months

  3. Change in weight from Baseline to 12-months among Veterans (using EHR data)

    Baseline weight is measured using a study-provided scale during a scheduled virtual study visit. To examine durability of intervention effects while minimizing participant burden, we will also obtain EHR-based weights at 12 months, using weights collected 365 days +/- 90 days post-baseline among only Veterans.

    Time frame: 12-months

  4. Change in self-reported diet quality from Baseline to 6-months among Veterans

    This outcome is measured by self-report using the eight-item Starting the Conversation measure.

    Time frame: 6-months

  5. Change in self-reported diet quality from Baseline to 6-months among partners

    This outcome is measured by self-report using the eight-item Starting the Conversation measure.

    Time frame: 6-months

  6. Change in physical activity from Baseline to 6-months among Veterans

    This outcome is measured by self-report using the 9-item International Physical Activity Questionnaire-Short Form.

    Time frame: 6-months

  7. Change in physical activity from Baseline to 6-months among partners

    This outcome is measured by self-report using the 9-item International Physical Activity Questionnaire-Short Form.

    Time frame: 6-months

  8. Change in relationship quality from Baseline to 6 months among Veterans

    This outcome is assessed by self-report with the seven-item Relationship Assessment Scale, revised for non-romantic relationships.

    Time frame: 6-months

  9. Change in relationship quality from Baseline to 6 months among partners

    This outcome is assessed by self-report with the seven-item Relationship Assessment Scale, revised for non-romantic relationships.

    Time frame: 6-months

07

Study locations

2 of 2 sites recruiting
08

References and documents

Publications

  • Gray KE, Benson S, Robustelli BL, Perez L, Taylor L, Nelson KM, Hoerster KD. Protocol for HealthyTogether: A randomized controlled trial testing a virtual, dyadic weight management intervention for a veteran and a support person. Contemp Clin Trials. 2026 Jun;165:108309. doi: 10.1016/j.cct.2026.108309. Epub 2026 Apr 13. PubMed 41985657 ↗

Individual participant data

Plan to share: No — Data will be made available outside VA in response to a properly prepared Freedom of Information Act request submitted to the VA Puget Sound FOIA Officer, or submitted and passed down to the facility FOIA Officer from higher VA authority (e.g. VISN 20 or Central Office). Such requests will be evaluated in terms of protecting potential intellectual property value and rights of VA and its employees, collaborators and research sponsors, and any other proprietary or security concerns, including protection of Personal Identifiable Information (PII) and Protected Health Information (PHI), terms of Confidentiality Agreements or other such restrictions and protections.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2025 (actual). Primary completion is estimated for Sep 2027, 26 months after the start.

Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 26 months is above that.

Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 26, 2024
First posted
Oct 1, 2024
StartActual
Jul 14, 2025
Primary completionEst.
Sep 30, 2027
CompletionEst.
Sep 30, 2028
Last update
Sep 1, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06619041
Responsible party
Sponsor
First posted
Oct 1, 2024
Start date
Jul 14, 2025
Primary completion
Sep 30, 2027 (estimated)
Completion
Sep 30, 2028 (estimated)
Last update
Sep 1, 2026

Study contacts

Kristen E Gray, PhD MS BS
Contact
Kristen.Gray2@va.gov
(206) 764-2056
Katherine D Hoerster, PhD MPH BA
Contact
Katherine.Hoerster@va.gov
(206) 277-4203
Kristen E. Gray, PhD MS BS
principal investigator · VA Puget Sound Health Care System Seattle Division, Seattle, WA

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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